Plexus Brachialis Block. Better to do by Start Than by En... | NCT01740141

Studies
Plexus Brachialis Block. Better to do by Start Than by End of Surgery?

NCT01740141

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Plexus brachialis block

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Apr 2016Actual

First Submitted Date

Nov 22, 2012

First Submission Date that Met QC Criteria

Nov 29, 2012

First Posted Date

Dec 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery.

This is a prospective, randomized, double blind study in patients with radial fractures undergoing surgery with volar plate. The patients will be followed up for 6 months after surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plexus before surgery	Other	Plexus brachialis before surgery	Procedure: Plexus brachialis block
Plexus after surgery	Other	Plexus brachialis performed after surgery	Procedure: Plexus brachialis block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plexus brachialis block	Procedure		Plexus after surgery Plexus before surgery	LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	NAS	postoperative to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radial fracture
ASA 1 and 2
Able to communicate in norwegian
Suitable for surgery in general anaesthesia and brachial plexus block

Exclusion Criteria:

Pregnancy
Chronic pain
BMI over 35

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Holmberg, MD	MD Ullevaal sykehus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten		Oslo	Oslo	0540	Norway

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided